Kelly Davio

September 05, 2018

Two research letters, published concurrently in the Journal of the American Medical Association, focused on biosimilars and their role in the Medicare population.

September 04, 2018

Janssen’s drug, sold in New Zealand as Eprex (and in the United States as Epogen) would lose funding after a transition period beginning in February 2019. After the close of the transition, only Novartis’ approved biosimilar, sold as Binocrit, would be eligible for funding in community and hospital settings.

September 03, 2018

IgG4-related disease (IgG4-RD), a systemic disease that can affect any part of the body and can involve fibrosis, irreversible organ damage, and secondary amyloidosis, is a rare immune-mediated condition often treated with corticosteroids or immunosuppressive drugs. The pathogenesis of the disease is not clear, but treatment with B-cell depletion therapy, in the form of rituximab, has shown positive results in some patients.

August 31, 2018

August 2018 saw a variety of developments in the policy landscape for biosimilars, both in the United States and worldwide.

August 30, 2018

“This comes down to the assiduous care you must do for any clinical studies using human subjects…you don’t experiment on human beings unless you’re really going to learn something,” said Gillian R. Woollett, MA, DPhil, senior vice president of Avalere Health.

August 29, 2018

“Misleading statements...and the net impression conveyed by such materials, create undue confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt on the safety and efficacy of biosimilars generally,” read Pfizer's citizen petition.

August 28, 2018

The World Health Organization (WHO) has published a new report on reimbursement policies in Europe that provides a comparative review and analysis of the policies employed by 45 different European countries, and says that promoting the uptake of lower-priced medicines such as generics and biosimilars will “facilitate efficiency gains without disadvantaging patients.”

August 27, 2018

Sandoz, with its filgrastim biosimilar (Zarxio) having been the first biosimilar to gain FDA approval and to launch in the US market, has had extensive experience in the biosimilars space. Carlos Sattler, MD, head of clinical development and medical affairs at Sandoz, recently spoke with The Center for Biosimilars® about both the biosimilar development process and the regulatory landscape that lies ahead.

August 27, 2018

There was a significant difference observed in pain scores between pediatric patients receiving pegfilgrastim versus those receiving filgrastim after allogenic hematopoietic stem cell transplantation.

August 26, 2018

The government is asking pharmaceutical companies to stockpile an additional 6-week supply of medicine, on top of their usual stock levels, in case normal supply routes through the European Union are disrupted.